SPC changes
Accessing SPCs
The summaries of product characteristics and patient
information leaflets for medicines licensed in the UK are available online |
Duloxetine
Warnings about suicidal thoughts have been added to the summaries of
product characteristics for Cymbalta (duloxetine; Lilly) and Yentreve
(duloxetine; Lilly).
Meptid
Additional information about treatment of overdose has been included
in the summary of product characteristics for Meptid (meptazinol; Shire)
tablets.
Pioglitazone
Information about an increased risk of fractures has been added to the
summaries of product characteristics for Actos (pioglitazone; Takeda)
and Competact (pioglitazone, metformin; Takeda).
Sprycel
Starting dose information has been updated in the summary of product
characteristics for Sprycel (dasatinib; Bristol-Myers Squibb). 100mg
once daily is now specified as the starting dose for patients with
chronic phase chronic myeloid leukaemia (CML) that is resistant or
intolerant to prior therapy, including imatinib.
For patients with
advanced (accelerated or blast) phase CML resistant or intolerant
to prior therapy (including imatinib), or Philadelphia chromosome positive
acute lymphoblastic leukaemia resistant or intolerant to prior therapy,
the starting dose remains 70mg twice a day.
Stalevo
Additional information is now included in the special warnings of the
summary of product characteristics for Stalevo (levodopa, carbidopa,
entacarpone; Orion). It now states: “For patients who experience
progressive anorexia, asthenia and weight decrease within a relatively
short period of time, a general medical evaluation including liver
function should be considered.”
Colitis; discoloration of skin,
hair, beard and nails; and hepatitis with cholestatic features have
been added to the undesirable effects section of the SPC.
Zyprexa
Elevated cholesterol levels has been added to the lists of common side
effects (1–10 per cent) in the summaries of product characteristics
for Zyprexa (olanzapine; Lilly) products. The special warnings sections
of the SPCs contain a new statement about lipid alteration in patients
treated with olanzapine.
Back to Top
|
The
Pharmaceutical Journal